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Procedure
Sacral Neuromodulation for Chronic Pelvic Pain (SNM_CPP Trial)
N/A
Waitlist Available
Led By Kenneth Peters, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failed at least 1 or more conservative treatments (e.g. pelvic floor physical therapy, biofeedback, behavioral modification, oral pharmacotherapy, bladder instillations)
Female, aged 22-70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (2 weeks post-implant), visit 4 (10 weeks post-implant), visit 5 (an average of 11-15 weeks post-implant), visit 7 (12 months post-implant), and visit 8 (an average of 13 months post-implant)
Awards & highlights
SNM_CPP Trial Summary
This trial is testing a safe, minimally invasive implant procedure to treat chronic pelvic pain in women, which has been approved by the FDA.
Who is the study for?
Women aged 22-70 with chronic pelvic pain who've tried at least one treatment without success can join. They mustn't change their pain meds for 4 weeks before the trial, use effective birth control, and commit to the study's duration. Exclusions include pelvic cancer history, severe medical conditions that could affect results, certain concurrent pain treatments, psychiatric disorders as judged by the physician (except stable depression or anxiety), frequent UTIs, uncontrolled diabetes with nerve issues, prior SNM device or trial participation, allergies to specific materials in the device components (titanium etc.), spinal cord stimulators/drug pumps implanted regardless of status (on/off), breastfeeding or pregnant women not using contraception properly.Check my eligibility
What is being tested?
The trial is testing sacral neuromodulation—a minimally invasive procedure where a small device is implanted—to see if it helps women suffering from chronic pelvic pain. The effectiveness will be measured throughout the study period after a single implantation procedure.See study design
What are the potential side effects?
Sacral neuromodulation may cause discomfort at the implant site, lead migration which might require repositioning of leads during follow-up visits; infection risk around the implant area; potential technical problems with the device itself; and possible interference with bodily functions controlled by sacral nerves.
SNM_CPP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least one non-surgical treatment without success.
Select...
I am a woman aged between 22 and 70.
SNM_CPP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2 (2 weeks post-implant), visit 4 (10 weeks post-implant), visit 5 (an average of 11-15 weeks post-implant), visit 7 (12 months post-implant), and visit 8 (an average of 13 months post-implant)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (2 weeks post-implant), visit 4 (10 weeks post-implant), visit 5 (an average of 11-15 weeks post-implant), visit 7 (12 months post-implant), and visit 8 (an average of 13 months post-implant)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
Secondary outcome measures
Change in Female Sexual Function
Change in mental health and anxiety.
Change in pelvic floor pain using a 10-point VAS pain score.
+6 moreSNM_CPP Trial Design
1Treatment groups
Experimental Treatment
Group I: SNM for the treatment of CPPExperimental Treatment1 Intervention
Patients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacral neuromodulation
2018
N/A
~140
Find a Location
Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,833 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital Royal, Oak
26 Previous Clinical Trials
2,001 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to participate in this investigation?
"The requirements for enrollment in this clinical trial are chronic pelvic pain syndrome and an age range between 22 and 70. This particular medical research is set to accept approximately 25 patients."
Answered by AI
Are individuals aged 35 or more eligible for this experimental program?
"Prospective participants must meet the age requirement of between 22 and 70 years old to be considered eligible for this clinical trial."
Answered by AI
Are there vacancies for individuals to partake in this experiment?
"Clinicaltrials.gov reveals that this medical trial, originally posted on December 1st 2023, is not currently recruiting participants. However, 39 other studies are actively accepting volunteers at this time."
Answered by AI
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